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Intravenous Dilution Guidelines

Piperacillin/Tazobactam (Zosyn ®)

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents

D5W, NS

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Primary:
Use 'Ready-made infusion bags': Zosyn (piperacillin and tazobactam injection) in Galaxy® Container (PL 2040 Plastic) is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in single-dose plastic containers

Secondary (If ready-made infusion bags are not available):
Extemporaneous preparation using single dose vials:
[2.25 grams] [50 ml] [30 min]
[3.375 grams] [100 ml] [30 min]
[4.5 grams] [100 ml] [30 min]

Stability / Miscellaneous

EXP: 1 DAY (RT) / 7 DAYS (REF). Label: Refrigerate.
Cannot be given IM.

DOSAGE AND ADMINISTRATION
Zosyn should be administered by intravenous infusion over 30 minutes.
The usual daily dose of Zosyn for adults is 3.375 g every six hours.

Nosocomial Pneumonia
Initial presumptive treatment of patients with nosocomial pneumonia should start with Zosyn at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.

Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Zosyn and the aminoglycoside are recommended for separate administration. Zosyn and the aminoglycoside should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated.

Renal Insufficiency
In patients with renal insufficiency (Creatinine Clearance less than or equal 40 mL/min), the intravenous dose of Zosyn (piperacillin and tazobactam for injection) should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendations of the manufacturer. The recommended daily doses of Zosyn for patients with renal insufficiency are as follows: Recommended Dosing of Zosyn in Patients with Normal Renal Function and Renal Insufficiency (As total grams piperacillin/tazobactam)

Renal Function
(Creatinine Clearance, mL/min)
All Indications (except nosocomial pneumonia) Nosocomial Pneumonia
* Creatinine clearance for patients not receiving hemodialysis
** 0.75 g should be administered following each hemodialysis session on hemodialysis days
>40 mL/min 3.375 q 6 h 4.5 q 6 h
20-40 mL/min* 2.25 q 6 h 3.375 q 6 h
<20 mL/min* 2.25 q 8 h 2.25 q 6 h
Hemodialysis** 2.25 q 12 h 2.25 q 8 h
CAPD 2.25 q 12 h 2.25 q 8 h

For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g Zosyn should be administered following each dialysis period on hemodialysis days. No additional dosage of Zosyn is necessary for CAPD patients.

Duration of Therapy
The usual duration of Zosyn treatment is from seven to ten days. However, the recommended duration of Zosyn treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.


Directions for Reconstitution and Dilution for Use
Intravenous Administration
Pharmacy Bulk Package
Not for Direct Infusion

RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION
The pharmacy bulk vial is for use in a hospital pharmacy admixture service only under a laminar flow hood. After reconstitution, entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and contents should be dispensed as aliquots into intravenous solution using aseptic technique. Use entire contents of pharmacy bulk vial promptly. Discard unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Reconstitute the pharmacy bulk vial with exactly 152 mL of a compatible reconstitution diluent, listed below, to a concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Shake well until dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

Compatible Reconstitution Diluents
0.9% Sodium Chloride for Injection
Sterile Water for Injection‡
Dextrose 5%
Bacteriostatic Saline/Parabens
Bacteriostatic Water/Parabens
Bacteriostatic Saline/Benzyl Alcohol
Bacteriostatic Water/Benzyl Alcohol

Reconstituted Zosyn solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed below. Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Compatible Intravenous Solutions
0.9% Sodium Chloride for Injection
Sterile Water for Injection‡
Dextran 6% in Saline
Dextrose 5%
Lactated Ringer's Solution (Compatible only with reformulated Zosyn containing EDTA)

‡Maximum recommended volume per dose of Sterile Water for Injection is 50 mL.

Zosyn should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

Zosyn is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

Zosyn should not be added to blood products or albumin hydrolysates.

Zosyn can be used in ambulatory intravenous infusion pumps.

Stability of Zosyn Following Reconstitution
Zosyn is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.

The pharmacy bulk vial should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Stability studies in the I.V. bags have demonstrated chemical stability [potency, pH of reconstituted solution, and clarity of solution] for up to 24 hours at room temperature and up to one week at refrigerated temperature. Zosyn contains no preservatives. Appropriate consideration of aseptic technique should be used.

Stability of Zosyn (piperacillin and tazobactam for injection) in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature. Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL. One-day supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions. Stability of Zosyn is not affected when administered using an ambulatory intravenous infusion pump.

Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED
Zosyn® (piperacillin and tazobactam for injection) is supplied as a powder in the pharmacy bulk vial as follows:

Each Zosyn 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams tazobactam, 9 mg of edetate disodium dihydrate (EDTA) and 1800 mg of sodium citrate. Each pharmacy bulk vial contains 100.4 mEq (2,304 mg) of sodium.
NDC 0206-8859-10

Zosyn (piperacillin and tazobactam for injection) pharmacy bulk vials should be stored at controlled room temperature 20°C to 25°C (68°F to 77°F) prior to reconstitution.

Also Available
Zosyn (piperacillin and tazobactam for injection) is also supplied as follows:

2.25 g single-dose vial containing piperacillin sodium equivalent to 2 g of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 5.58 mEq (128 mg) of sodium. Supplied 10/box—NDC 0206-8852-16

3.375 g single-dose vial containing piperacillin sodium equivalent to 3 g of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 8.38 mEq (192 mg) of sodium. Supplied 10/box—NDC 0206-8854-16

4.5 g single-dose vial containing piperacillin sodium equivalent to 4 g of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 11.17 mEq (256 mg) of sodium. Supplied 10/box—NDC 0206-8855-16

Zosyn (piperacillin and tazobactam for injection) is also supplied in the ADD-Vantage® Vial as follows:

2.25 g ADD-Vantage® vial (piperacillin sodium equivalent to 2 g piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam). Each ADD-Vantage® vial contains 5.58 mEq (128 mg) of sodium. Supplied 10/box—NDC 0206-8852-18

3.375 g ADD-Vantage® vial (piperacillin sodium equivalent to 3 g piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam). Each ADD-Vantage® vial contains 8.38 mEq (192 mg) of sodium. Supplied 10/box—NDC 0206-8854-18

4.5 g ADD-Vantage® vial (piperacillin sodium equivalent to 4 g piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam). Each ADD-Vantage® vial contains 11.17 mEq (256 mg) of sodium. Supplied 10/box—NDC 0206-8855-18

Also Available
Zosyn (piperacillin and tazobactam injection) in Galaxy® Container (PL 2040 Plastic) is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in single-dose plastic containers as follows:

2.25 g (piperacillin sodium equivalent to 2 g piperacillin/tazobactam sodium equivalent to 0.25 g tazobactam) in 50 mL. Each container has 5.58 mEq (128 mg) of sodium. Supplied 24/box—NDC 0206-8860-02

3.375 g (piperacillin sodium equivalent to 3 g piperacillin/tazobactam sodium equivalent to 0.375 g tazobactam) in 50 mL. Each container has 8.38 mEq (192 mg) of sodium. Supplied 24/box—NDC 0206-8861-02

4.5 g (piperacillin sodium equivalent to 4 g piperacillin/tazobactam sodium equivalent to 0.5 g tazobactam) in 100 mL. Each container has 11.17 mEq (256 mg) of sodium. Supplied 12/box—NDC 0206-8862-02


CLINITEST® and DIASTIX® are registered trademarks of Ames Division, Miles Laboratories, Inc.
TES-TAPE® is a registered trademark of Eli Lilly and Company.
Galaxy® is a registered trademark of Baxter International, Inc.
ADD-Vantage® is a registered trademark of Abbott Laboratories.

Wyeth®
Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101
W10416C010
ET01
Rev 02/07


Source: [package insert]
Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.  PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
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